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  6. TOC Analyzer for the Pharmaceutical Industry - Sievers M9

TOC Analyzer for the Pharmaceutical Industry - Sievers M9

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Sievers M9

last updated:May 26, 2025

セントラル科学
セントラル科学
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Rapid / Easy / Accurate TOC Measurement

The Sievers M9 can accommodate a variety of applications due to its unique gas-permeable membrane conductivity measurement method and wide measurement range (0.03 ppb to 50 ppm). Features of the Sievers M9: - No carrier gas required - Stability in ultra-low concentration range - 12 months of calibration stability - Three models to choose from based on application (laboratory type/portable type/online type) - Compliance with data integrity requirements based on 21 CFR Part 11 (optional) - The sample conductivity measurement function allows simultaneous measurement of TOC and conductivity (USP<645> Stage 1) (optional) - An auto-sampler can automatically analyze up to 63 samples (40mL) (optional)

    Analytical Equipment and Devices
M9.png

TOC Analyzer for the Pharmaceutical Industry - Sievers M9

M9.png
M9.png オートサンプラーのみ3-1.png
  • Related Link - https://aqua-ckc.jp/products/toc_m9
  • Special site - Product/service details - https://pr.mono.ipros.com/aqua-ckc/product/

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basic information

- Total Organic Carbon (TOC) Measurement Principle: Wet UV oxidation + gas permeable membrane conductivity measurement method Measurement Range: 0.03 ppb to 50 ppm TOC Accuracy: ±2% or 0.5 ppb, whichever is greater Reproducibility: RSD less than 1% Display Digits: 3 digits Calibration Frequency: Recommended every 12 months Measurement Interval: 2 minutes Interfering Substances: Not affected by coexisting ions other than organic substances - Equipment Power Requirements: 100–240 V, 50/60 Hz, 100 VA Ambient Temperature: 5–40 °C Humidity: Up to 95% without condensation Dimensions: Varies by model Weight: Varies by model (9.8 kg to 16.2 kg) *For detailed specifications, please refer to the catalog.

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Applications/Examples of results

- Measurement of pharmaceutical water - Cleaning validation - TOC analysis of leachables in USP<661> (Plastic Packaging Systems and Their Components)

Detailed information

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    - Sievers' unique gas permeable membrane conductivity measurement method In the TOC measurement method for conductivity, the conductivity indicated by the carbon dioxide (carbonate ions) generated after the oxidation and decomposition of organic matter is measured to calculate the carbon concentration. The Sievers M500e enables accurate TOC measurement by using a "gas permeable membrane module," which separates carbon dioxide from the sample water to the pure water line within the analyzer through a thin Teflon film, thereby eliminating the influence of other ions.

Line up(5)

Model number overview
SPRD77110-01 TOC Meter M9 Laboratory Type
SPRD77115-01 TOC Meter M9 Laboratory Type (with Conductivity Measurement Function)
SPRD77210-01 TOC Meter M9 Portable Type
SPRD77215-01 TOC Meter M9 Portable Type (with Conductivity Measurement Function)
SPRD77310-01 TOC Meter M9 Online Type

catalog(50)

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Comparison of TOC Analysis Methods in Cleaning Validation (Lab_Atline_Online)

Comparison of TOC Analysis Methods in Cleaning Validation (Lab_Atline_Online)

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Pharmaceutical Water _ TOC Meter for Cleaning Validation Sievers M9

Pharmaceutical Water _ TOC Meter for Cleaning Validation Sievers M9

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Comparison of TOC measurements in the cleaning validation of protein samples.

Comparison of TOC measurements in the cleaning validation of protein samples.

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Sievers solutions for pharmaceutical applications

Sievers solutions for pharmaceutical applications

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Commercially available low-concentration conductivity standard solution.

Commercially available low-concentration conductivity standard solution.

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Comparison of measurement principles of TOC (Total Organic Carbon) analysis (combustion catalyst oxidation method and gas permeable membrane conductivity measurement method)

Comparison of measurement principles of TOC (Total Organic Carbon) analysis (combustion catalyst oxidation method and gas permeable membrane conductivity measurement method)

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Swab TOC recovery rate of the compound in the worst-case scenario (feasibility test)

Swab TOC recovery rate of the compound in the worst-case scenario (feasibility test)

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Real-time release through online cleaning validation using total organic carbon, inorganic carbon, and conductivity data.

Real-time release through online cleaning validation using total organic carbon, inorganic carbon, and conductivity data.

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TOC recovery rate of complex compounds: cleaning agents

TOC recovery rate of complex compounds: cleaning agents

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Comparison of TOC Cleaning Validation Swab Kits.

Comparison of TOC Cleaning Validation Swab Kits.

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TOC measurement of 0.2M sodium hydroxide using the Sievers M9 type.

TOC measurement of 0.2M sodium hydroxide using the Sievers M9 type.

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TOC measurement of 0.2M potassium hydroxide using the Sievers M9 type.

TOC measurement of 0.2M potassium hydroxide using the Sievers M9 type.

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Simultaneous measurement of TOC and conductivity to analyze non-conductive organic substances in cleaning agents.

Simultaneous measurement of TOC and conductivity to analyze non-conductive organic substances in cleaning agents.

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TOC recovery rate using STERIS Life Sciences' cleaning agent_Sievers M9 type

TOC recovery rate using STERIS Life Sciences' cleaning agent_Sievers M9 type

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Validation of TOC Method for Cleaning Validation in the Pharmaceutical Industry

Validation of TOC Method for Cleaning Validation in the Pharmaceutical Industry

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Calculation of Maximum Allowable Carryover (MAC) in Cleaning Validation

Calculation of Maximum Allowable Carryover (MAC) in Cleaning Validation

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Sievers Validation Support Package for Cleaning Validation

Sievers Validation Support Package for Cleaning Validation

TECHNICAL
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PAT Application: At-line TOC measurement for cleaning validation and product changeover.

PAT Application: At-line TOC measurement for cleaning validation and product changeover.

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Reduction of cleaning validation and product changeover costs by 92% through in-line TOC measurement.

Reduction of cleaning validation and product changeover costs by 92% through in-line TOC measurement.

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Cleaning validation: Verifying the performance of the cleaning process.

Cleaning validation: Verifying the performance of the cleaning process.

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Evaluation of the validity of cleaning standards based on engineering capability index

Evaluation of the validity of cleaning standards based on engineering capability index

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Analysis method for cleaning validation

Analysis method for cleaning validation

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Detection of TOC and conductivity of CIP-100 using the Sievers M series.

Detection of TOC and conductivity of CIP-100 using the Sievers M series.

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TOC recovery rate of insoluble and difficult-to-decompose compounds

TOC recovery rate of insoluble and difficult-to-decompose compounds

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Cost comparison of TOC and HPLC (using TOC analyzers for cleaning validation)

Cost comparison of TOC and HPLC (using TOC analyzers for cleaning validation)

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Sievers M9 type used for lab_atline_online_cleaning_validation

Sievers M9 type used for lab_atline_online_cleaning_validation

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Real-time low-flow cleaning efficacy evaluation of pharmaceuticals using TOC and conductivity.

Real-time low-flow cleaning efficacy evaluation of pharmaceuticals using TOC and conductivity.

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Cleaning evaluation: Microbial TOC recovery rate and linearity

Cleaning evaluation: Microbial TOC recovery rate and linearity

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Best Practices for Measuring Conductivity of Sievers M9 Type in Pharmaceutical Water

Best Practices for Measuring Conductivity of Sievers M9 Type in Pharmaceutical Water

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Measurement of conductivity and TOC using Sievers M9.

Measurement of conductivity and TOC using Sievers M9.

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Sievers M9 Conductivity Measurement USP 645 Improvement of Stage 1 Robustness and Best Practices

Sievers M9 Conductivity Measurement USP 645 Improvement of Stage 1 Robustness and Best Practices

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TOC & Conductivity Sample Storage Container

TOC & Conductivity Sample Storage Container

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Conductivity & TOC Sampling Standard Operating Procedure

Conductivity & TOC Sampling Standard Operating Procedure

MANUAL
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Simultaneous measurement of TOC and conductivity for efficiency improvement and cost reduction.

Simultaneous measurement of TOC and conductivity for efficiency improvement and cost reduction.

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Suitability of Conductivity Measurement for M9_EP Monograph_EP2.2.38_USP645

Suitability of Conductivity Measurement for M9_EP Monograph_EP2.2.38_USP645

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Simultaneous measurement of conductivity USP Stage 1 and TOC of pharmaceutical water in the lab.

Simultaneous measurement of conductivity USP Stage 1 and TOC of pharmaceutical water in the lab.

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Screening of USP 661.1 plastic packaging materials using the TOC meter Sievers M9 type.

Screening of USP 661.1 plastic packaging materials using the TOC meter Sievers M9 type.

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TOC analysis of leachables in USP661 (Plastic Packaging Systems and Materials).

TOC analysis of leachables in USP661 (Plastic Packaging Systems and Materials).

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Conductivity Bridging Study: From Laboratory Conductivity Meter to Sievers M9 Type

Conductivity Bridging Study: From Laboratory Conductivity Meter to Sievers M9 Type

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Real-time test validation support package for pharmaceutical water.

Real-time test validation support package for pharmaceutical water.

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Transition of TOC analysis method for cleaning validation from the lab to At-Line PAT.

Transition of TOC analysis method for cleaning validation from the lab to At-Line PAT.

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Online TOC Analyzer Sievers M500

Online TOC Analyzer Sievers M500

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Conductivity & TOC dual-use (DUCT) vial

Conductivity & TOC dual-use (DUCT) vial

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Performance and Stability of DUCT Vials

Performance and Stability of DUCT Vials

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Five Tips for Successful Cleaning Validation

Five Tips for Successful Cleaning Validation

TECHNICAL
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TOC Analyzer for Pharmaceuticals Sievers M9

TOC Analyzer for Pharmaceuticals Sievers M9

PRODUCT
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Cleaning Validation: Transition from HPLC to TOC - Three Factors to Consider

Cleaning Validation: Transition from HPLC to TOC - Three Factors to Consider

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Sievers TOC Sensor CheckPoint Pharma

Sievers TOC Sensor CheckPoint Pharma

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Sievers Products Standard Solutions & Consumables Catalog

Sievers Products Standard Solutions & Consumables Catalog

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Revision of EP regulations: New standards for TOC testing and new standard values by container capacity.

Revision of EP regulations: New standards for TOC testing and new standard values by container capacity.

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News about this product(2)

Are you ready for the system suitability testing of the TOC analyzer compliant with the European Pharmacopoeia (EP 12.3) revision?

  • Catalog news

The revision of the EP that came into effect on July 1, 2026, has significantly changed the requirements for the system suitability test (SST) of TOC analyzers. After the implementation of EP 12.3, in order to clarify standardization and traceability within the EP, the standard solutions for the system suitability test of TOC analyzers must use sucrose and 1,4-benzoquinone, which are certified as EP reference substances (Chemical Reference Substances: CRS). With the EP standard solution becoming the new standard, if USP standard solutions are to be continued, it is necessary to explain the validity of adopting USP reference substances. We have published a page on our website that explains the key points of the revision, necessary responses, considerations for continuing to use USP standard solutions, and ways to utilize EP standard solutions to reduce operational burdens. If you are considering how to respond to the EP revision, please take a look at the related links. Additionally, in the related materials, we provide detailed information on the requirements for standard solutions, reference values by container type, and comparative evaluation results using Sievers TOC analyzers, highlighting key points for quality control and regulatory compliance of pharmaceutical water.

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[Notice of Exhibition Participation] Announcement of Participation in CPHI Japan 2026

  • Seminar・Event

~Exhibiting measurement instruments for pharmaceutical water management centered around Sievers brand products~ Central Science Co., Ltd. will exhibit at "CPhI Japan 2026 (International Pharmaceutical Development Exhibition)" held at Tokyo Big Sight from April 21 (Tuesday) to April 23 (Thursday), 2026. At this exhibition, we will focus on products from the Sievers brand and introduce various measurement instruments used for pharmaceutical water management and cleaning validation. Through the display of actual devices, you can confirm the features of the measurements and the operational image. - Main exhibited products Sievers TOC Analyzer M9 Sievers Online TOC Analyzer M500 Sievers BioBurden Rapid Measurement Device Soleil Sievers Endotoxin Analyzer Eclipse If you are interested in improving the efficiency of water quality management and quality assurance operations in the pharmaceutical and biotech fields, please stop by our booth.

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セントラル科学

セントラル科学

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Since our establishment in 1967, we have been dedicated to the development and dissemination of water quality measurement devices that anyone can use quickly, easily, and with high precision. In today's world, where the effective use of water, a limited resource, is required alongside environmental conservation, we aim to be a total solution provider that responds to all water environments by utilizing our water quality measurement devices, technology, and services. Furthermore, leveraging the latest technology and years of know-how, we are committed to delivering user-friendly and reliable water quality measurement devices more affordably, quickly, and widely.

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